CAPLYTA Q2 2024 net product sales were $161.3 million, compared to $110.1 million for the same period in 2023, representing a 46% increase CAPLYTA's strong prescription uptake continues: Q2 2024 CAPLYTA total prescriptions increased 36%, versus the same period in 2023 CAPLYTA 2024 net product sales guidance raised to $650 to $680 million Announced positive Phase 3 results from Study 501 and Study 502 evaluating lumateperone as an adjunctive therapy to antidepressants in patients with major depressive disord ...

CAPLYTA Q2 2024 net product sales were $161.3 million, compared to $110.1 million for the same period in 2023, representing a 46% increase CAPLYTA's strong prescription uptake continues: Q2 2024 CAPLYTA total prescriptions increased 36%, versus the same period in 2023 CAPLYTA 2024 net product sales guidance raised to $650 to $680 million Announced positive Phase 3 results from Study 501 and Study 502 evaluating lumateperone as an adjunctive therapy to antidepressants in patients with major depressive disord ...

Core Insights - Intra-Cellular Therapies, Inc. will host a conference call and live webcast on August 7, 2024, to provide a corporate update and discuss financial results for the quarter ended June 30, 2024 [1] Company Overview - Intra-Cellular Therapies is a biopharmaceutical company focused on developing therapeutics for central nervous system disorders, leveraging Nobel prize-winning research to understand cellular mechanisms [4] - The company aims to create innovative treatments for complex psychiatric and neurologic diseases [4]

Year to date, shares of Intra-Cellular have gained 6.9% against the industry's 5.8% decline. Please note that the company is simultaneously evaluating lumateperone for several other indications. The most prominent of the additional indications being pursued for the drug is major depressive disorder (MDD). In the first half of 2024, the company reported achieving the primary and key secondary efficacy endpoints in two global phase III studies, 501 and 502, evaluating 42 mg of lumateperone as an adjunctive th ...

Core Insights - Intra-Cellular Therapies (ITCI) announced positive top-line results from Study 502, the second late-stage study evaluating lumateperone 42 mg for major depressive disorder (MDD) [1] - The study achieved statistically significant and clinically meaningful results in both primary and key secondary endpoints, indicating the drug's effectiveness [4][11] Study Results - Study 502 demonstrated a statistically significant reduction in the Montgomery-Åsberg Depression Rating Scale (MADRS) total score compared to placebo at week six [11] - The key secondary endpoint showed a significant reduction in the Clinical Global Impression Scale score at week six [2] - Improvement in depressive symptoms was also noted through the Quick Inventory of Depressive Symptomatology Self Report (QIDS-SR-16) [3] Safety Profile - Lumateperone was generally safe and well-tolerated, with most adverse events being mild to moderate in severity [6] - Safety data from Study 502 aligns with previous studies of lumateperone for MDD, bipolar depression, and schizophrenia [6] Regulatory and Market Implications - The success of Studies 501 and 502 supports a regulatory filing for label expansion of lumateperone as an adjunctive treatment for MDD, anticipated in the second half of 2024 [14] - If approved, the eligible patient population for Caplyta will expand, potentially boosting revenues for the company [22] Market Performance - Following the announcement of positive results, ITCI's stock climbed 9.6% on June 18, with a year-to-date gain of 5.4% compared to the industry's 7.1% decline [15]

Intra-Cellular Therapies (ITCI) shares rallied 9.6% in the last trading session to close at $75.48. This move can be attributable to notable volume with a higher number of shares being traded than in a typical session. This compares to the stock's 5.4% gain over the past four weeks. This biopharmaceutical company is expected to post quarterly loss of $0.20 per share in its upcoming report, which represents a year-over-year change of +55.6%. Revenues are expected to be $157.59 million, up 42.2% from the year ...

Lumateperone 42 mg met the primary endpoint of change from baseline at Week 6 on the Montgomery-Åsberg Depression Rating Scale (MADRS) total score versus placebo (4.5 point reduction v. placebo; p<0.0001; Cohen's d effect size (ES)=0.56) Statistically significant efficacy was also seen in the Quick Inventory of Depressive Symptomatology SelfReport (QIDS-SR) scale, a patient self-reported measure of symptom severity of depression (p<0.0001) Supplemental NDA (sNDA) submission for the adjunctive treatment of m ...

The live and archived webcast can be accessed under "Events & Presentations" in the Investor Relations section of the Company's website at www.intracellulartherapies.com. Please log in approximately 5-10 minutes prior to the event to register and to download and install any necessary software. Burns McClellan, Inc. Cameron Radinovic cradinovic@burnsmc.com 646-930-4406 Intra-Cellular Therapies is a biopharmaceutical company founded on Nobel prize-winning research that allows us to understand how therapies af ...

NEW YORK, May 29, 2024 (GLOBE NEWSWIRE) -- Intra-Cellular Therapies, Inc. (NASDAQ:ITCI), a biopharmaceutical company focused on the development and commercialization of therapeutics for central nervous system (CNS) disorders, today announced that Sharon Mates, Ph.D., Chief Executive Officer and Chairman, is scheduled to present at the Jefferies Global Healthcare Conference on Wednesday, June 5, 2024 at 11:00 a.m. ET in New York, NY. The live and archived webcast can be accessed under "Events & Presentations ...

The analyses being presented provide important information about CAPLYTA's efficacy, safety and tolerability profile in patients with bipolar I and II disorder and in patients with major depressive disorder (MDD) suffering from a major depressive episode and exhibiting mixed features. ASCP Presentations: CAPLYTA® (lumateperone) is indicated in adults for the treatment of schizophrenia and depressive episodes associated with bipolar I or II disorder (bipolar depression) as monotherapy and as adjunctive thera ...